Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
| Registry | NCT03221023, acronym IV-DIRT |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 900 (Estimated) |
| Sponsor | University of British Columbia (Other) |
| Conditions | Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection |
| Interventions | Vancomycin Hydrochloride, Saline Solution (Drug) |
| Dates | start 2017-09-15, primary completion 2021-09-15 (estimated), completion 2021-12-15 (estimated), first posted 2017-07-18, last updated 2020-10-30 |
| Locations | 1 site in Canada |
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The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.
Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.
The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.
This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.
The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vancomycin | Experimental | Drug: Vancomycin Hydrochloride; Drug: Saline Solution | These patients will receive intrawound Vancomycin-saline and IV antibiotics |
| Saline | Placebo comparator | Drug: Saline Solution | These patients will receive intrawound saline + IV antibiotics alone |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * individuals who require INS replacement from Dr. C.R. Honey * individuals who are between the ages of 18 to 80. * individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon * individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively * individuals who are capable of providing informed consent Exclusion Criteria: * individuals who have a history of autoimmune disease * individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study * individuals who are on immunosuppression or any medication that would influence infection susceptibility * individuals who are allergic to Vancomycin or Cefazolin
| Facility | City | Country | Status |
|---|---|---|---|
| Vancouver General Hospital | Vancouver, British Columbia | Canada | Recruiting |